PANATUSS PED- chlophedianol hydrchloride, dexchlorpheniramine maleate, pseudoephedrine hydrochloride solution/ drops

Panatuss PED by

Drug Labeling and Warnings

Panatuss PED by is a Otc medication manufactured, distributed, or labeled by Seyer Pharmatec, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                         Purpose
(in each 1 mL)

Chlophedianol HCl 6.25 mg ...................... Cough Suppressant

Dexchlorpheniramine Maleate 0.5 mg ......... Antihistamine

Pseudoephedrine HCl 15 mg ................... Nasal Decongestant

PURPOSE

Purpose

Cough Suppressant

Antihistamine

Nasal Decongestant

INDICATIONS & USAGE

Uses

Temporarily calms cough due to minor throat and bronchial irritation as may occur with the common cold

• calms the cough control center and relieves coughing
• non narcotic cough suppressant for the temporary relief of cough
• temporarily relieves runny nose and alleviates sneezing, itching of the nose or throat and itchy, watery eyes due to hay fever or other upper respiratory allergies
• temporarily relieves nasal congestion due to the common cold
• helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
  

WARNINGS

Warnings

• do not exceed recommended dosage
• a persistent cough may be sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor

Ask a doctor before use if a child has

• a persistent or chronic cough such as occurs with asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma

Ask a doctor before use if a child is taking sedatives or tranquilizers.

When using this product

• excitability may occur, especially in children
• may cause marked drowsiness
• sedatives and tranquilizers may increase the drowsiness effect

DO NOT USE

Do not use

• in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
• if symptoms do not improve within 7 days or are accompanied by fever, rash or persistent headache.
  

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

• take every 6 hours, not to exceed 4 doses in 24 hours or as directed by a physician

• Children 6 to under 12 years of age: 2 mL
• Children 2 to under 6 years of age: Ask a doctor
• Children under 2 years of age: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients

Citric acid, flavor, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose, xanthan gum

QUESTIONS

Questions or comments?1-888-782-3585

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PANATUSS PED 
chlophedianol hydrchloride, dexchlorpheniramine maleate, pseudoephedrine hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11026-2785
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	6.25 mg  in 1 mL
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N)	DEXCHLORPHENIRAMINE MALEATE	0.5 mg  in 1 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	FRUIT (Tropical Fruit)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11026-2785-2	1 in 1 CARTON
1		60 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/15/2012

Labeler - Seyer Pharmatec, Inc. (832947126)